TS EN 60601-1-8 Electrical Medical Equipment - Part 1-8: General Requirements for Basic Safety and Required Performance - Auxiliary Standard: General Requirements, Experiments and Guidelines for Electrical Medical Equipment and Warning Systems in Electrical Medical Systems

The EN 60601-1-8 standard, developed by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), describes the basic safety and performance characteristics and test methods of warning systems in electrical medical equipment. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 60601-1-8 Electrical medical equipment - Part 1-8: General requirements for basic safety and required performance - Auxiliary standard: Electrical medical equipment and electrical medical General requirements, tests and guidance for warning systems in systems.

This standard has replaced the following standards:

• ISO 9703-1 Alarm signals of anesthesia and respiratory therapy devices - Part 1: Visual alarm signals
• ISO 9703-2 Alarm signals of anesthesia and respiratory therapy devices - Part 2: Auditory alarm signals
• ISO 9703-3 Alarm signals of anesthesia and respiratory therapy devices - Part 3: Guidance on the implementation of alarms

EN 60601-1-8 contains requirements for alarm systems and alarm signals in electrical medical equipment and medical systems, and provides guidance on the implementation of alarm systems.

Essentially, the EN 60601 series of standards are assurance standards and describe safety requirements for equipment such as:

• A subgroup of electrical medical equipment, such as radiological equipment
• Electrical medical equipment not fully addressed in general standards

The EN 60601-1-8 standard does not cover such situations:

• HWhether any electrical medical equipment or electrical medical system needs alarm systems
• Exceptions that trigger an alarm state
• Priorities allocation to a specific alarm situation
• Tools for generating alarm signals

Our organization also provides basic safety and performance testing services of warning systems in EN 60601-1-8 electrical medical equipment within the scope of laboratory services.